Sedadex (dexmedetomidine hydrochloride) – Package leaflet - QN05CM18

Updated on site: 21-Sep-2017

Namn på medicinering: Sedadex
ATC: QN05CM18
Ämne: dexmedetomidine hydrochloride
Tillverkare: Le Vet Beheer B.V.

PACKAGE LEAFLET FOR

Sedadex 0.1 mg/ml solution for injection for dogs and cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Name:

Le Vet Beheer B.V.

Address:

Wilgenweg 7

 

3421 TV Oudewater

 

The Netherlands

Manufacturer responsible for batch release:

Name:

Produlab Pharma B.V.

Address:

Forellenweg 16

 

4941 SJ Raamsdonksveer

 

The Netherlands

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 ml contains:

 

Active substance:

 

Dexmedetomidine hydrochloride

0.1 mg

(equivalent to dexmedetomidine

0.08 mg)

Excipients:

 

Methyl parahydroxybenzoate (E 218)

2.0 mg

Propyl parahydroxybenzoate

0.2 mg

Clear, colourless solution for injection.

4.INDICATION(S)

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.

5.CONTRAINDICATIONS

Do not use in animals with cardiovascular disorders.

Do not use in animals with severe systemic disease or in animals that are moribund.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

6.ADVERSE REACTIONS

By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.

In some dogs and cats, a decrease in respiratory rate may occur. Rare instances of pulmonary oedema have been reported. Blood pressure will increase initially and then return to normal or below normal. Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/or with a blue tinge.

Vomiting may occur 5-10 minutes after injection. Some dogs and cats may also vomit at the time of recovery.

Muscle tremors may occur during sedation.

Corneal opacities may occur during sedation (see also the section on Special precautions for the use in animals).

When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole. Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea. In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia. Vomiting, hypothermia and nervousness have been reported after such use.

When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur. Brady- and tachyarrhythmias have been reported.

These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.

When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur. Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.

When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur. Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Dogs and cats

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The veterinary medicinal product is intended for:

-Dogs: intravenous or intramuscular use

-Cats: intramuscular use

The veterinary medicinal product is not intended for repeat injections.

Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.

The following doses are recommended:

Dogs:

Dexmedetomidine doses are based on body surface area:

For non-invasive, mildly to moderately painful procedures and examinations requiring restraint, sedation and analgesia:

Intravenously: up to 375 micrograms/square metre body surface area. Intramuscularly: up to 500 micrograms/square metre body surface area.

When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.

The premedication dose of dexmedetomidine is 125 – 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia. The dose should be adjusted to the type of surgery, length of procedure and patient temperament.

Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes after administration. The peak sedative and analgesic effects are reached within 30 minutes after administration. Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes. Spontaneous recovery occurs within 3 hours.

Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect. In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 – 4 hours. However this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.

The corresponding doses based on body weight are presented in the following tables. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.

Dog

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine

Weight

125 micrograms/m2

375 micrograms/m2

500 micrograms/m2*

(kg)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

9.4

0.2

28.1

0.6

0.75

8.3

0.25

0.85

7.7

0.35

1.5

5.1-10

6.5

0.5

19.6

1.45

10.1-13

5.6

0.65

16.8

1.9

 

 

13.1-15

5.2

0.75

 

 

 

 

15.1-20

4.9

0.85

 

 

 

 

*only intramuscularly

 

 

 

 

 

 

 

 

 

 

 

For deep sedation and analgesia with butorphanol

 

 

 

 

 

 

 

Dog

 

 

Dexmedetomidine

 

 

Weight

 

300 micrograms/m2 intramuscularly

 

(kg)

 

(mcg/kg)

 

 

(ml)

 

 

 

 

0.6

 

 

 

 

0.8

 

 

22.2

 

 

 

5.1-10

 

16.7

 

 

1.25

 

10.1-13

 

 

 

1.5

 

13.1-15

 

12.5

 

 

1.75

 

For higher weight ranges, use Sedadex 0.5 mg/ml and its dosing tables.

Cats:

The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.

When dexmedetomidine is used for premedication in cats, the same dose is used. Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol was reduced by 50%. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect.

Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw or by intravenous administration of propofol to effect. Dosing for cats is presented in the following table.

Cat

 

 

Weight

Dexmedetomidine 40 micrograms/kg intramuscularly

(kg)

(mcg/kg)

(ml)

0.5

For higher weight ranges, use Sedadex 0.5 mg/ml and its dosing table.

9.ADVICE ON CORRECT ADMINISTRATION

The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration. Sedation may be reversed with atipamezole (see section 12 overdose). Atipamezole should not be administered prior to 30 minutes following ketamine administration.

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Shelf-life after first opening the immediate packaging: 56 days.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the package after EXP.

The expiry date refers to the last day of that month.

12.SPECIAL WARNINGS

Special warnings

The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.

Special precautions for use in animals

Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.

It is recommended that animals are fasted for 12 hours prior to Sedadex administration. Water may be given.

After treatment, the animal should not be given water or food before it is able to swallow.

Corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. To be used with precaution in elderly animals.

The safety of dexmedetomidine has not been established in males intended for breeding.

Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.

Frequent and regular monitoring of respiratory and cardiac function should be performed. Pulse oximetry may be useful but is not essential for adequate monitoring. Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats. It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.

Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.

Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction medicinal product required for induction of anaesthesia. Attention should be given during the administration of intravenous induction medicinal products to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Dexmedetomidine is a sedative and sleep inducing drug. Care should be taken to avoid self-injection. In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.

Pregnant women should administer the product with special caution to avoid self-injection since uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.

Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin. In case of eye contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.

Advice to physicians: Sedadex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically. The specific α2 – adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.

Use during pregnancy and lactation

The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species. Therefore the use of the product during pregnancy and lactation is not recommended.

Interactions with other medicinal products and other forms of interaction

The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made. Anticholinergics should be used with caution with dexmedetomidine.

Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period. Within 15 minutes dogs and cats are normally awake and standing.

Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on Tmax. The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.

A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.

Atipamezole does not reverse the effect of ketamine.

Overdose (symptoms, emergency procedures, antidotes)

Dogs:

In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area). The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Sedadex 0.1 mg/ml that was given to the dog, regardless of route of administration of Sedadex.

Cats:

In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw. The dose volume of atipamezole at the

concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat.

After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.

Incompatibilities None known.

Dexmedetomidine is compatible with butorphanol and ketamine in the same syringe at least for two hours.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15.OTHER INFORMATION

Colourless Type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

Pack size: 1 vial.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Luxembourg/Luxemburg

Kela Veterinaria N.V./S.A.

Kela Veterinaria N.V./S.A.

Industriepark west 68

Industriepark west 68

9100 Sint-Niklaas

9100 Sint-Niklaas

Tél/Tel: + 32 (0)3-7806390

BELGIUM

info@kelavet.be

Tél/Tel: + 32 (0)3-7806390

 

info@kelavet.be

Република България

Magyarország

Le Vet Beheer B.V.

Alpha-Vet

Wilgenweg 7

Állatgyógyászati Kft.

3421 TV Oudewater

8000 Székesfehérvár

THE NETHERLANDS

Homoksor 7.

Teл: +31-(0)348-565858

Tel.: +36-22/516402

info@levetpharma.com

vevoszolgalat@alpha-vet.hu

Danmark

Nederland

Dechra Veterinary Products A/S

AST Farma B.V.

Mekuvej 9

Wilgenweg 7

7171 Uldum

3421 TV Oudewater

Tlf: +45 7690 1100

Tel: +31-(0)348-563434

 

info@astfarma.nl

 

Deutschland

Le Vet Beheer B.V. Wilgenweg 7

3421 TV Oudewater THE NETHERLANDS Tel: +31-(0)348-565858 info@levetpharma.com

Eesti

Zoovetvaru

Uusaru 5

Saue 76505 Harjumaa Tel: +372-6709006 zoovet@zoovet.ee

Ελλάδα

Petline S.A.

Finos Film Road, Thesi Xousmiza 19004 Spata-Attikis

Τηλ: +30-(0)210 6069800 info@petline.gr

España

B. Braun VetCare SA Carretera de Terrassa 121 E-08191 Rubi (Barcelona) Tel: +34 93 586 62 00

France

Dechra Veterinary Products SAS 60 Avenue du Centre

78180 Montigny-le-Bretonneux Tél: +33 1 3048 7140

Ireland

Animalcare Limited

10 Great North Way

York Business Park

Nether Poppleton York YO26 6RB

UNITED KINGDOM

Tel: +44 (0)1904 487687

Ísland

Icevet

P.O. Box 374

602 Akureyri

Sími: +354 544 2240 icevet@icevet.is

Norge

Dechra Veterinary Products AS

Henrik Ibsens Gate 90

0255 Oslo

Tlf: +47 48 02 07 98

Österreich

Richter Pharma AG Feldgasse 19

4600 Wels

Tel. +43 7242 4900 office@richter-pharma.at

Polska

aniMedica Polska Sp. z o.o. ul. Chwaszcyńska 198a 81-571 Gdynia

Tel: +48 58 572 24 38

Portugal

B. Braun Medical, Lda. Est. Consiglieri Pedroso, 80

Queluz Park – Queluz de Baixo P-2730-053 Barcarena

Tel: +351 21 4368251

România

Maravet S.A. Baia Mare cod 430016

Str. Maravet nr.1 Tel: +40262211964

Slovenija

TPR d.o.o. Litostrojska c. 44E 1000 Ljubljana

Tel: +386 1 505 58 82 info@medvet.si

Slovenská republika

Sevaron, s.r.o. Palackého třída 163a 612 00 Brno CZECH REPUBLIC Tel: +420 541426370 info@sevaron.cz

Italia

Suomi/Finland

Ecuphar Italia S.R.L.

FaunaPharma Oy. C/O Oriola Oy

Viale Francesco Restelli 3/7, piano 1,

P.O. Box 8

20124 Milano (Italia)

FIN-02101 Espoo

Tel. + 39 0282950604

Puh/Tel: +358 45 2300 665

 

info@faunapharma.fi

Κύπρος

Sverige

Le Vet Beheer B.V.

Dechra Veterinary Products AB

Wilgenweg 7

Stora Wäsby Orangeriet 3

3421 TV Oudewater

19437 Upplands Väsby

THE NETHERLANDS

Tel: +46 (0) 8 32 53 55

Τηλ: +31-(0)348-565858

 

info@levetpharma.com

 

Latvija

United Kingdom

Zoovetvaru

Animalcare Limited

Uusaru 5

10 Great North Way

Saue 76505 Harjumaa

York Business Park

ESTONIA

Nether Poppleton York YO26 6RB

Tel: +372-6709006

Tel: +44 (0)1904 487687

zoovet@zoovet.ee

 

Lietuva

Hrvatska

Zoovetvaru

TPR d.o.o.

Uusaru 5

Litostrojska c. 44E

Saue 76505 Harjumaa

1000 Ljubljana

ESTONIA

SLOVENIA

Tel: +372-6709006

Tel: +386 1 505 58 82

zoovet@zoovet.ee

info@medvet.si

PACKAGE LEAFLET FOR

Sedadex 0.5 mg/ml solution for injection for dogs and cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Name:

Le Vet Beheer B.V.

Address:

Wilgenweg 7

 

3421 TV Oudewater

 

The Netherlands

Manufacturer responsible for batch release:

Name:

Produlab Pharma B.V.

Address:

Forellenweg 16

 

4941 SJ Raamsdonksveer

 

The Netherlands

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sedadex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 ml contains:

 

Active substance:

 

Dexmedetomidine hydrochloride

0.5 mg

(equivalent to dexmedetomidine

0.42 mg)

Excipient(s):

 

Methyl parahydroxybenzoate (E 218)

1.6 mg

Propyl parahydroxybenzoate

0.2 mg

Clear, colourless solution for injection.

4. INDICATION(S)

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.

5. CONTRAINDICATIONS

Do not use in animals with cardiovascular disorders.

Do not use in animals with severe systemic disease or in animals that are moribund.

Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

6. ADVERSE REACTIONS

By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.

In some dogs and cats a decrease in respiratory rate may occur. Rare instances of pulmonary oedema have been reported. Blood pressure will increase initially and then return to normal or below normal. Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/or with a blue tinge.

Vomiting may occur 5-10 minutes after injection. Some dogs and cats may also vomit at the time of recovery.

Muscle tremors may occur during sedation.

Corneal opacities may occur during sedation (see also the section on Special precautions for the use in animals).

When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole. Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea. In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia. Vomiting, hypothermia and nervousness have been reported after such use.

When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur. Brady- and tachyarrhythmias have been reported.

These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.

When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea and vomiting may occur. Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.

When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur. Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs and cats

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The veterinary medicinal product is intended for:

-Dogs: intravenous or intramuscular use

-Cats: intramuscular use

The veterinary medicinal product is not intended for repeat injections.

Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.

The following doses are recommended:

Dogs:

Dexmedetomidine doses are based on body surface area:

For non-invasive, mildly to moderately painful procedures and examinations requiring restraint, sedation and analgesia:

Intravenously: up to 375 micrograms/square metre body surface area. Intramuscularly: up to 500 micrograms/square metre body surface area

When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.

The premedication dose of dexmedetomidine is 125 – 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia. The dose should be adjusted to the type of surgery, length of procedure and patient temperament.

Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes after administration. The peak sedative and analgesic effects are reached within 30 minutes after administration. Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes. Spontaneous recovery occurs within 3 hours.

Premedication with dexmedetomidine will significantly reduce the dosage of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect. In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 – 4 hours. However this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.

The corresponding doses based on body weight are presented in the following tables. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.

Dog

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine

Weight

125 micrograms/m2

375 micrograms/m2

500 micrograms/m2*

(kg)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

9.4

0.04

28.1

0.12

0.15

8.3

0.05

0.17

0.2

7.7

0.07

0.2

0.3

5.1-10

6.5

0.1

19.6

0.29

0.4

10.1-13

5.6

0.13

16.8

0.38

0.5

13.1-15

5.2

0.15

15.7

0.44

0.6

15.1-20

4.9

0.17

14.6

0.51

0.7

20.1-25

4.5

0.2

13.4

0.6

0.8

25.1-30

4.2

0.23

12.6

0.69

0.9

30.1-33

0.25

0.75

1.0

33.1-37

3.9

0.27

11.6

0.81

1.1

37.1-45

3.7

0.3

0.9

14.5

1.2

45.1-50

3.5

0.33

10.5

0.99

1.3

50.1-55

3.4

0.35

10.1

1.06

13.5

1.4

55.1-60

3.3

0.38

9.8

1.13

1.5

60.1-65

3.2

0.4

9.5

1.19

12.8

1.6

65.1-70

3.1

0.42

9.3

1.26

12.5

1.7

70.1-80

0.45

1.35

12.3

1.8

>80

2.9

0.47

8.7

1.42

1.9

*only intramuscularly

 

For deep sedation and analgesia with butorphanol

 

 

 

Dog

 

Dexmedetomidine

Weight

300 micrograms/m2 intramuscularly

(kg)

(mcg/kg)

(ml)

0.12

0.16

22.2

0.2

5.1-10

16.7

0.25

10.1-13

0.3

13.1-15

12.5

0.35

15.1-20

11.4

0.4

20.1-25

11.1

0.5

25.1-30

0.55

30.1-33

9.5

0.6

33.1-37

9.3

0.65

37.1-45

8.5

0.7

45.1-50

8.4

0.8

50.1-55

8.1

0.85

55.1-60

7.8

0.9

60.1-65

7.6

0.95

65.1-70

7.4

70.1-80

7.3

1.1

>80

1.2

 

 

Cats:

The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.

When dexmedetomidine is used for premedication in cats, the same dose is used. Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol was reduced by 50%. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect.

Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw or by intravenous administration of propofol to effect. Dosing for cats is presented in the following table.

Cat

Dexmedetomidine 40 micrograms/kg intramuscularly

Weight

 

 

(kg)

(mcg/kg)

(ml)

0.1

0.2

0.3

0.4

0.5

0.6

8.1-10

0.7

9. ADVICE ON CORRECT ADMINISTRATION

The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration. Sedation may be reversed with atipamezole (see section 12 overdose). Atipamezole should not be administered prior to 30 minutes following ketamine administration.

10. WITHDRAWAL PERIOD

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Shelf-life after first opening the immediate packaging: 56 days.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the package after EXP.

The expiry date refers to the last day of that month.

12. SPECIAL WARNINGS

Special warnings

The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.

Special precautions for use in animals

Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.

It is recommended that animals are fasted for 12 hours prior to Sedadex administration. Water may be given.

After treatment, the animal should not be given water or food before it is able to swallow.

Corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. To be used with precaution in elderly animals.

The safety of dexmedetomidine has not been established in males intended for breeding.

Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.

Frequent and regular monitoring of respiratory and cardiac function should be performed. Pulse oximetry may be useful but is not essential for adequate monitoring. Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats. It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.

Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.

Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction medicinal product required for induction of anaesthesia. Attention should be given during the administration of intravenous induction medicinal products to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Dexmedetomidine is a sedative and sleep inducing drug. Care should be taken to avoid self-injection. In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.

Pregnant women should administer the product with special caution to avoid self-injection since uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.

Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin. In case of eye contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

People with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.

Advice to physicians: Sedadex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically. The specific α2 – adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.

Use during pregnancy and lactation

The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species. Therefore the use of the product during pregnancy and lactation is not recommended.

Interactions with other medicinal products and other forms of interaction

The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made. Anticholinergics should be used with caution with dexmedetomidine.

Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period. Within 15 minutes dogs and cats are normally awake and standing.

Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on Tmax. The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.

A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.

Atipamezole does not reverse the effect of ketamine.

Overdose (symptoms, emergency procedures, antidotes)

Dogs:

In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area). The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Sedadex 0.5 mg/ml that was given to the dog, regardless of route of administration of Sedadex.

Cats:

In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw. The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Sedadex 0.5 mg/ml that was given to the cat.

After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.

Incompatibilities None known.

Dexmedetomidine is compatible with butorphanol and ketamine in the same syringe at least for two hours.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15. OTHER INFORMATION

Colourless Type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

Pack size: 1 vial.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Kela Veterinaria N.V./S.A. Industriepark west 68 9100 Sint-Niklaas

Tél/Tel: + 32 (0)3-7806390 info@kelavet.be

Република България

Le Vet Beheer B.V. Wilgenweg 7

3421 TV Oudewater THE NETHERLANDS Teл: +31-(0)348-565858 info@levetpharma.com

Česká republika

Sevaron, s.r.o. Palackého třída 163a 612 00 Brno

Tel: +420 541426370 info@sevaron.cz

Danmark

Dechra Veterinary Products A/S

Mekuvej 9

7171 Uldum

Tlf: +45 7690 1100

Deutschland

Le Vet Beheer B.V. Wilgenweg 7

3421 TV Oudewater THE NETHERLANDS Tel: +31-(0)348-565858 info@levetpharma.com

Eesti

Zoovetvaru

Uusaru 5

Saue 76505 Harjumaa Tel: +372-6709006 zoovet@zoovet.ee

Ελλάδα

Petline S.A.

Finos Film Road, Thesi Xousmiza 19004 Spata-Attikis

Τηλ: +30-(0)210 6069800 info@petline.gr

Luxembourg/Luxemburg

Kela Veterinaria N.V./S.A. Industriepark west 68 9100 Sint-Niklaas BELGIUM

Tél/Tel: + 32 (0)3-7806390 info@kelavet.be

Magyarország

Alpha-Vet Állatgyógyászati Kft. 8000 Székesfehérvár Homoksor 7.

Tel.: +36-22/516402 vevoszolgalat@alpha-vet.hu

Malta

Le Vet Beheer B.V. Wilgenweg 7

3421 TV Oudewater THE NETHERLANDS Tel: +31-(0)348-565858 info@levetpharma.com

Nederland

AST Farma B.V. Wilgenweg 7

3421 TV Oudewater Tel: +31-(0)348-563434 info@astfarma.nl

Norge

Dechra Veterinary Products AS

Henrik Ibsens Gate 90

0255 Oslo

Tlf: +47 48 02 07 98

Österreich

Richter Pharma AG Feldgasse 19

4600 Wels

Tel. +43 7242 4900 office@richter-pharma.at

Polska

aniMedica Polska Sp. z o.o. ul. Chwaszcyńska 198a 81-571 Gdynia

Tel: +48 58 572 24 38

España

Portugal

B. Braun VetCare SA

B. Braun Medical, Lda.

Carretera de Terrassa 121

Est. Consiglieri Pedroso, 80

E-08191 Rubi (Barcelona)

Queluz Park – Queluz de Baixo

Tel: +34 93 586 62 00

P-2730-053 Barcarena

 

Tel: +351 21 4368251

France

România

Dechra Veterinary Products SAS

Maravet S.A.

60 Avenue du Centre

Baia Mare

78180 Montigny-le-Bretonneux

cod 430016

Tél: +33 1 3048 7140

Str. Maravet nr.1

 

Tel: +40262211964

Ireland

Slovenija

Animalcare Limited

TPR d.o.o.

10 Great North Way

Litostrojska c. 44E

York Business Park

1000 Ljubljana

Nether Poppleton York YO26 6RB

Tel: +386 1 505 58 82

UNITED KINGDOM

info@medvet.si

Tel: +44 (0)1904 487687

 

Ísland

Slovenská republika

Icevet

Sevaron, s.r.o.

P.O. Box 374

Palackého třída 163a

602 Akureyri

612 00 Brno

Sími: +354 544 2240

CZECH REPUBLIC

icevet@icevet.is

Tel: +420 541426370

 

info@sevaron.cz

Italia

Suomi/Finland

Ecuphar Italia S.R.L.

FaunaPharma Oy. C/O Oriola Oy

Viale Francesco Restelli 3/7, piano 1,

P.O. Box 8

20124 Milano (Italia)

FIN-02101 Espoo

Tel. + 39 0282950604

Puh/Tel: +358 45 2300 665

 

info@faunapharma.fi

Κύπρος

Sverige

Le Vet Beheer B.V.

Dechra Veterinary Products AB

Wilgenweg 7

Stora Wäsby Orangeriet 3

3421 TV Oudewater

19437 Upplands Väsby

THE NETHERLANDS

Tel: +46 (0) 8 32 53 55

Τηλ: +31-(0)348-565858

 

info@levetpharma.com

 

Latvija

United Kingdom

Zoovetvaru

Animalcare Limited

Uusaru 5

10 Great North Way

Saue 76505 Harjumaa

York Business Park

ESTONIA

Nether Poppleton York YO26 6RB

Tel: +372-6709006

Tel: +44 (0)1904 487687

zoovet@zoovet.ee

 

 

Lietuva

Hrvatska

Zoovetvaru

TPR d.o.o.

Uusaru 5

Litostrojska c. 44E

Saue 76505 Harjumaa

1000 Ljubljana

ESTONIA

SLOVENIA

Tel: +372-6709006

Tel: +386 1 505 58 82

zoovet@zoovet.ee

info@medvet.si

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